search
Back to results

Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device (SV3-ST)

Primary Purpose

Sleep Disordered Breathing

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BiPAP S/T
BiPAP Auto SV3
Sponsored by
Philips Respironics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disordered Breathing

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 21-80.
  • Ability to provide consent.
  • Documentation of medical stability by investigator.
  • Currently using BiPAP S/T (At least 4 weeks on therapy).
  • Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.

Exclusion Criteria:

  • Participants, who are acutely ill, medically complicated or who are medically unstable.
  • Participants in whom PAP therapy is otherwise medically contraindicated.
  • Participants who are unwilling to wear PAP.
  • Participants who are currently prescribed oxygen therapy.
  • Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
  • Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
  • Participants with untreated, non-obstructive sleep apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome Periodic Limb Movement (PLM) Arousal Index > 15).
  • Participants who are unwilling to participate in the study.

Sites / Locations

  • Med One Medical Sleep Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Respironics BiPAP S/T

Respironics BiPAP Auto SV3

Arm Description

Control Arm using Respironics BiPAP S/T

Treatment arm using Respironics BiPAP Auto SV3

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index
The number of apneas and hypopneas per hour of sleep.

Secondary Outcome Measures

Apnea Hypopnea Index- REM
The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).
Central Apnea Index
The central apnea index is the number of central apneas divided by the number of hours of sleep.
Obstructive Apnea Index
The obstructive apnea index is the number of obstructive apneas per hour of sleep.
Mixed Apnea Index
The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.
Hypopnea Index
The hypopnea index is number hypopneas per hour.
Sleep Onset Latency
Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off.
REM Onset Latency
REM Onset Latency is the time it takes to fall into REM sleep.
Wake After Sleep Onset
Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.
Total Sleep Time
Total Sleep time is total amount of time a participant is asleep from lights off to lights on.
Sleep Efficiency
Sleep Efficiency is the percentage of time spent asleep while in bed.
Periodic Limb Movement Index
The periodic limb movement is the number of periodic limb movements per hour of sleep.
Arousal Index
The arousal index is the number of arousals or awakenings per hour of sleep.
Stages N1,N2,N3 and REM (R) Sleep (% TST)
The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.
Stages N1,N2,N3 and REM (R) Sleep (in Minutes)
The average amount of time spent N1, N2, N3 and REM in minutes per night.
Nocturnal Oxygenation Index
Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.
Apnea Hypopnea Index Using Modified Hypopnea Rule.
The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.
Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.

Full Information

First Posted
June 2, 2009
Last Updated
March 15, 2019
Sponsor
Philips Respironics
search

1. Study Identification

Unique Protocol Identification Number
NCT01241604
Brief Title
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
Acronym
SV3-ST
Official Title
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Sub par recruitment performance
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.
Detailed Description
Primary Hypothesis and end-point: The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than when compared to the BiPAP S/T device with respect to: Apnea-Hypopnea Index (AHI) Secondary Hypothesis and end-points: The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than the BiPAP S/T device, with respect to: Sleep Variables REM, NREM and Total Sleep Time (TST) Indices Apnea Hypopnea Index (AHI) Center Apnea Index(CAI) Obstructive Apnea Index (OAI) Mixed Apnea Index (MAI) Hypopnea Index (HI) Sleep Onset Latency (SOL) REM Onset Latency (ROL) Wake After Sleep Onset (WASO) Total Sleep Time (TST) Sleep Efficiency (SE %) Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (in minutes) Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST) Arousal Index [total, AH-related, PLM-related, 'spontaneous'] Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study) AHI (REM, NREM and TST) using modified hypopnea rule. AHI (REM, NREM and TST) during epochs for which leak is determined to exist within acceptable limits

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered Breathing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respironics BiPAP S/T
Arm Type
Active Comparator
Arm Description
Control Arm using Respironics BiPAP S/T
Arm Title
Respironics BiPAP Auto SV3
Arm Type
Active Comparator
Arm Description
Treatment arm using Respironics BiPAP Auto SV3
Intervention Type
Device
Intervention Name(s)
BiPAP S/T
Other Intervention Name(s)
Respironics BiPAP S/T
Intervention Description
Mechanical Non-invasive Ventilation
Intervention Type
Device
Intervention Name(s)
BiPAP Auto SV3
Other Intervention Name(s)
Respironics BiPAP auto SV Advanced
Intervention Description
Auto Servo Ventilation Device
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index
Description
The number of apneas and hypopneas per hour of sleep.
Time Frame
2 nights
Secondary Outcome Measure Information:
Title
Apnea Hypopnea Index- REM
Description
The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).
Time Frame
2 nights
Title
Central Apnea Index
Description
The central apnea index is the number of central apneas divided by the number of hours of sleep.
Time Frame
2 nights
Title
Obstructive Apnea Index
Description
The obstructive apnea index is the number of obstructive apneas per hour of sleep.
Time Frame
2 nights
Title
Mixed Apnea Index
Description
The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.
Time Frame
2 nights
Title
Hypopnea Index
Description
The hypopnea index is number hypopneas per hour.
Time Frame
2 nights
Title
Sleep Onset Latency
Description
Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off.
Time Frame
2 nights
Title
REM Onset Latency
Description
REM Onset Latency is the time it takes to fall into REM sleep.
Time Frame
2 nights
Title
Wake After Sleep Onset
Description
Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.
Time Frame
2 nights
Title
Total Sleep Time
Description
Total Sleep time is total amount of time a participant is asleep from lights off to lights on.
Time Frame
2 nights
Title
Sleep Efficiency
Description
Sleep Efficiency is the percentage of time spent asleep while in bed.
Time Frame
2 nights
Title
Periodic Limb Movement Index
Description
The periodic limb movement is the number of periodic limb movements per hour of sleep.
Time Frame
2 nights
Title
Arousal Index
Description
The arousal index is the number of arousals or awakenings per hour of sleep.
Time Frame
2 nights
Title
Stages N1,N2,N3 and REM (R) Sleep (% TST)
Description
The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.
Time Frame
2 nights
Title
Stages N1,N2,N3 and REM (R) Sleep (in Minutes)
Description
The average amount of time spent N1, N2, N3 and REM in minutes per night.
Time Frame
2 nights
Title
Nocturnal Oxygenation Index
Description
Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.
Time Frame
2 nights
Title
Apnea Hypopnea Index Using Modified Hypopnea Rule.
Description
The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.
Time Frame
2 nights
Title
Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
Description
The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.
Time Frame
2 nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 21-80. Ability to provide consent. Documentation of medical stability by investigator. Currently using BiPAP S/T (At least 4 weeks on therapy). Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration. Exclusion Criteria: Participants, who are acutely ill, medically complicated or who are medically unstable. Participants in whom PAP therapy is otherwise medically contraindicated. Participants who are unwilling to wear PAP. Participants who are currently prescribed oxygen therapy. Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg). Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days. Participants with untreated, non-obstructive sleep apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome Periodic Limb Movement (PLM) Arousal Index > 15). Participants who are unwilling to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brydon Grant, MD
Organizational Affiliation
Medical Director of Med One Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Med One Medical Sleep Laboratory
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

We'll reach out to this number within 24 hrs